Propranolol for the Treatment of Acute Stress Disorder
Status:
Completed
Trial end date:
2004-10-01
Target enrollment:
Participant gender:
Summary
This 10-week study will examine whether propranolol, a medication that blocks the activity of
the stress hormones adrenaline and noradrenaline, can relieve acute stress disorder (ASD) and
symptoms from persisting long-term. ASD is a condition that some people develop soon after
exposure to trauma. They may be anxious, depressed, have trouble sleeping, startle easily,
have difficulties concentrating, and feel as though the event is happening again. Propranolol
has been used for many years to treat high blood pressure and heart disease, and has been
found useful in treating anxiety states such as social phobia and migraine.
Men and women between 18 and 65 years of age who were recently exposed to trauma (between 1
and 3 weeks of evaluation in this study) may be eligible for this study. Candidates must be
diagnosed with ASD and must have been mentally healthy before the traumatic event. They will
be screened for the study with a medical and psychiatric interview, physical examination,
electrocardiogram (EKG), and blood and urine tests.
Participants will be evaluated with the following procedures:
- Neuropsychological tests using pen-and-paper and computer tests to evaluate cognitive
function, particularly memory, learning, attention and concentration, and vocabulary and
naming.
- Emotion-related performance tasks to determine if the study medication can weaken
emotionally arousing information by blocking the activity of adrenaline and
noradrenaline. Subjects perform emotion-related and neutral tasks, such as looking at
pictures with neutral, pleasant, or unpleasant content, both before and after treatment
with the study medication (see below).
- Traumatic script exposure: Subjects recount the traumatic event that caused them to
develop ASD. The description is summarized, recorded, and played back to the subject.
During the playback, physiological responses, such as heart rate and skin conductance
(sweating), are recorded using electrodes taped to the hand and chest.
- Fear conditioning to evaluate the response to an unpleasant stimulus: Several mild
electrical shocks are delivered to the wrists while the subject looks at colored
squares. Heart rate and skin conductance are measured.
- Magnetic resonance imaging (MRI) to examine brain structure. The subject lies on a table
that is moved into the MRI scanner (a narrow cylinder containing a strong magnetic
field) and must remain still during the actual scanning. Earplugs are worn to muffle
loud noises caused by electrical switching of radio frequency circuits used in the
scanning process.
After the evaluation, participants are randomly assigned to receive either propranolol or
placebo (a look-alike pill with no active ingredient) for 8 weeks During this time they are
seen by a doctor once a week for 4 weeks and then once every other week for the rest of the
study. At the end of the 8-week treatment period, participants undergo the same evaluation
they had before beginning treatment (see above). The decision to continue treatment will then
be decided based on the individual's clinical condition and whether he or she received
propranolol or placebo.